Caelyx as Primary Treatment for Patients With Breast Cancer and a History of Heart Disease and/or Age Over 65 Years

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter study of a primary chemotherapy regimen in breast cancer patients at risk of developing cardiotoxicity. The aim of the study is to evaluate the response rate at surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SOLTI Breast Cancer Research Group
• Collaborator: Schering-Plough
• Treatments: Doxorubicin; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• Histologically confirmed invasive breast cancer (tumor > 2 cm).

• Estrogen receptor-negative or -weakly positive tumors (less than 50% of cells), as evaluated using IHC.

• Risk factors for developing anthracycline-induced cardiomyopathy.

Exclusion Criteria:

• Severe heart failure (NYHA Class III or IV) .

• Metastatic disease.

• LVEF < 45%.

• Pregnant or breast-feeding patients.